Omnix Medical Receives U.S. FDA Approval of a Phase II Trial of its Next-Generation Anti-Infective OMN6
News provided byAKAMPION
Nov 20, 2023, 4:00 AM ET
- Phase I data show safety and tolerability at clinically significant dose levels
- New class of anti-infectives to treat infections with Gram-negative bacteria
JERUSALEM, Israel, November 20, 2023 -- Omnix Medical, a biopharmaceutical company developing next-generation anti-infectives for the treatment of life-threatening infections, today announced that the U.S. Food and Drug Administration (FDA) has approved a planned Phase II trial of the Company´s novel anti-infective OMN6.
The multinational, multicenter trial will assess the safety and pharmacokinetics of OMN6 in patients with hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP) caused by Acinetobacter baumannii complex (ABC).
Omnix Medical´s lead compound OMN6 is a novel, first-in-class antimicrobial peptide (AMP) based on insect host defense peptides. Its mechanism of action (MoA) is based on a totally novel principle compared to conventional anti-infectives:
the compound destroys bacterial cell membranes, enabling a fast and effective onset of action regardless of bacterial genotype or resistance phenotype.
In a randomized, double-blind, placebo-controlled, single ascending dose Phase I study with over 80 healthy volunteers, OMN6 has demonstrated excellent safety and tolerability at clinically significant dose levels. Moreover, complete clearance of the drug could be shown, allowing for multiple daily infusions as is common with anti-infective treatments.
"We are very pleased that the U.S. FDA has approved our planned Phase II study," said Dr. Moshik Cohen-Kutner, CEO of Omnix Medical. "As we have seen very encouraging results in our previous Phase I trial, we hope that the Phase II data will confirm these data. This would be a key milestone in the development of a novel class of anti-infectives that are not associated with a development of antimicrobial resistance."
Dr. Niv Bachnoff, CSO of Omnix Medical, added: "We look forward to initiating this Phase II trial in the coming months. Our goal is to provide a potent alternative to conventional anti-infectives and to save the lives of millions of patients worldwide who no longer respond to currently available antibiotics."
About Omnix Medical
Omnix Medical was founded in 2015 to address the urgent unmet need for new life-saving anti-infective drugs. Omnix´ proprietary technology eliminates bacteria by mimicking the innate immune system of insects which uses unique molecules to efficiently and selectively kill resistant bacterial strains without toxic effects. This mechanism, which is at the core of Omnix´ technology, kills bacteria upon contact and has successfully evolved over 200 million years. The Company’s lead compound is being developed for the treatment of life-threatening hospital-acquired infections (HIA) and has shown significantly higher potency than currently available treatments. Most importantly, Omnix´ technology prevents the development of new resistances and is thus well positioned to become the first-line-treatment to win the war against AMR.
OMN6 is a novel, first-in-class antimicrobial peptide (AMP) based on insect host defense peptides. Its mechanism of action (MoA) is based on disruption of bacterial cell membranes and is therefore effective regardless of bacterial genotype or resistance phenotype, and unlike conventional bacteriostatic antibiotics, it is fast acting and bactericidal. OMN6 has been optimized from the original AMP by Omnix Medical´s proprietary technology to exhibit not only remarkable efficacy, potency, and safety, but also high stability while maintaining bioactivity. As a result, Omnix Medical believes that its novel peptides can be considered a new class of antimicrobial drugs. OMN6, the Company's lead compound, is intended for the treatment of life-threatening infections caused by Gram-negative bacteria such as Acinetobacter baumannii.
Moshik Cohen-Kutner, CEO
Niv Bachnoff, CSO
Dr. Ludger Wess / Ines-Regina Buth
Tel. +49 40 88 16 59 64 /
Tel. +49 30 23 63 27 68
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